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Volumn 279, Issue 2, 2014, Pages 230-239

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

Author keywords

Alveolar macrophage; Biologics; GMCSF receptor; Mavrilimumab; Rheumatoid arthritis; Safety assessment

Indexed keywords

CHOLESTEROL; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; MAVRILIMUMAB;

EID: 84904252983     PISSN: 0041008X     EISSN: 10960333     Source Type: Journal    
DOI: 10.1016/j.taap.2014.06.002     Document Type: Article
Times cited : (16)

References (27)
  • 2
    • 80955177524 scopus 로고    scopus 로고
    • Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study
    • Burmester G.R., Feist E., Sleeman M.A., Wang B., White B., Magrini F. Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann. Rheum. Dis. 2011, 70(9):1542-1549.
    • (2011) Ann. Rheum. Dis. , vol.70 , Issue.9 , pp. 1542-1549
    • Burmester, G.R.1    Feist, E.2    Sleeman, M.A.3    Wang, B.4    White, B.5    Magrini, F.6
  • 4
    • 77950630228 scopus 로고    scopus 로고
    • The molecular basis of pulmonary alveolar proteinosis
    • Carey B., Trapnell B.C. The molecular basis of pulmonary alveolar proteinosis. Clin. Immunol. 2010, 135(2):223-235.
    • (2010) Clin. Immunol. , vol.135 , Issue.2 , pp. 223-235
    • Carey, B.1    Trapnell, B.C.2
  • 5
    • 75449123869 scopus 로고
    • Lymph Flow in the Lungs
    • Courtice F.C. Lymph Flow in the Lungs. Br. Med. Bull. 1963, 19(1):76.
    • (1963) Br. Med. Bull. , vol.19 , Issue.1 , pp. 76
    • Courtice, F.C.1
  • 6
    • 0028263504 scopus 로고
    • Involvement of granulocyte-macrophage colony stimulating factor in pulmonary homeostasis
    • Dranoff G., Crawford A.D., Sadelain M., et al. Involvement of granulocyte-macrophage colony stimulating factor in pulmonary homeostasis. Science 1994, 264:713-716.
    • (1994) Science , vol.264 , pp. 713-716
    • Dranoff, G.1    Crawford, A.D.2    Sadelain, M.3
  • 7
    • 33751069035 scopus 로고    scopus 로고
    • A review of background findings in cynomolgus monkeys (Macaca fascicularis) from three different geographical origins
    • Drevon-Gaillot E., Perron-Lepage M., Clement C., Burnett R. A review of background findings in cynomolgus monkeys (Macaca fascicularis) from three different geographical origins. Exp. Toxicol. Pathol. 2006, 58:77-88.
    • (2006) Exp. Toxicol. Pathol. , vol.58 , pp. 77-88
    • Drevon-Gaillot, E.1    Perron-Lepage, M.2    Clement, C.3    Burnett, R.4
  • 8
    • 84901328095 scopus 로고    scopus 로고
    • Challenges for inhaled drug discovery and development: induced alveolar macrophage responses
    • Forbes B., O'Lone R., Pribul Allen P., et al. Challenges for inhaled drug discovery and development: induced alveolar macrophage responses. Adv. Drug Deliv. Rev 2014, 10.1016/j.addr.2014.02.001.
    • (2014) Adv. Drug Deliv. Rev
    • Forbes, B.1    O'Lone, R.2    Pribul Allen, P.3
  • 9
    • 66149133635 scopus 로고    scopus 로고
    • Scleroderma Lung Study Research Group. Surfactant protein D and KL-6 as serum biomarkers of interstitial lung disease in patients with scleroderma
    • Hant F.N., Ludwicka-Bradley A., Wang H.J., Li N., Elashoff R., Tashkin D.P., Silver R.M. Scleroderma Lung Study Research Group. Surfactant protein D and KL-6 as serum biomarkers of interstitial lung disease in patients with scleroderma. J. Rheumatol. 2009, 36(4):773-780.
    • (2009) J. Rheumatol. , vol.36 , Issue.4 , pp. 773-780
    • Hant, F.N.1    Ludwicka-Bradley, A.2    Wang, H.J.3    Li, N.4    Elashoff, R.5    Tashkin, D.P.6    Silver, R.M.7
  • 10
    • 0036159142 scopus 로고    scopus 로고
    • Serum KL-6 levels in pediatric patients: reference values for children and levels in pneumonia, asthma, and measles patients
    • Imai T., Takase M., Takeda S., Kougo T. Serum KL-6 levels in pediatric patients: reference values for children and levels in pneumonia, asthma, and measles patients. Pediatr. Pulmonol. 2002, 33(2):135-141.
    • (2002) Pediatr. Pulmonol. , vol.33 , Issue.2 , pp. 135-141
    • Imai, T.1    Takase, M.2    Takeda, S.3    Kougo, T.4
  • 11
    • 79953068067 scopus 로고    scopus 로고
    • KL-6 concentration in pulmonary epithelial lining fluid is a useful prognostic indicator in patients with acute respiratory distress syndrome
    • Kondo T., Hattori N., Ishikawa N., Murai H., Haruta Y., Hirohashi N., et al. KL-6 concentration in pulmonary epithelial lining fluid is a useful prognostic indicator in patients with acute respiratory distress syndrome. Respir. Res. 2011, 12:32.
    • (2011) Respir. Res. , vol.12 , pp. 32
    • Kondo, T.1    Hattori, N.2    Ishikawa, N.3    Murai, H.4    Haruta, Y.5    Hirohashi, N.6
  • 12
    • 73549096677 scopus 로고    scopus 로고
    • Concentration of surfactant protein D, Clara cell protein CC-16 and IL-10 in bronchoalveolar lavage (BAL) in patients with sarcoidosis, hypersensivity pneumonitis and idiopathic pulmonary fibrosis
    • Kucejko W., Chyczewska E., Naumnik W., Ossolińska M. Concentration of surfactant protein D, Clara cell protein CC-16 and IL-10 in bronchoalveolar lavage (BAL) in patients with sarcoidosis, hypersensivity pneumonitis and idiopathic pulmonary fibrosis. Folia Histochem. Cytobiol. 2009, 47(2):225-230.
    • (2009) Folia Histochem. Cytobiol. , vol.47 , Issue.2 , pp. 225-230
    • Kucejko, W.1    Chyczewska, E.2    Naumnik, W.3    Ossolińska, M.4
  • 13
    • 84893639432 scopus 로고    scopus 로고
    • Foamy macrophage responses in the rat lung following exposure to inhaled pharmaceuticals: a simple, pragmatic approach for inhaled drug development
    • Lewis D.J., Williams T.C., Beck S.L. Foamy macrophage responses in the rat lung following exposure to inhaled pharmaceuticals: a simple, pragmatic approach for inhaled drug development. J. Appl. Toxicol. 2014, 34:319-331.
    • (2014) J. Appl. Toxicol. , vol.34 , pp. 319-331
    • Lewis, D.J.1    Williams, T.C.2    Beck, S.L.3
  • 16
    • 77953915044 scopus 로고    scopus 로고
    • Serum-surfactant SP-D correlates inversely to lung function in cystic fibrosis
    • Olesen H.V., Holmskov U., Schiøtz P.O., Sørensen G.L. Serum-surfactant SP-D correlates inversely to lung function in cystic fibrosis. J. Cyst. Fibros. 2010, 9(4):257-262.
    • (2010) J. Cyst. Fibros. , vol.9 , Issue.4 , pp. 257-262
    • Olesen, H.V.1    Holmskov, U.2    Schiøtz, P.O.3    Sørensen, G.L.4
  • 17
    • 0031817397 scopus 로고    scopus 로고
    • Granulocyte-macrophage colony-stimulating factor and pulmonary surfactant homeostasis
    • (Jul-Aug)
    • Reed J.A., Whitsett J.A. Granulocyte-macrophage colony-stimulating factor and pulmonary surfactant homeostasis. Proc. Assoc. Am. Physicians 1998, 110(4):321-332. (Jul-Aug).
    • (1998) Proc. Assoc. Am. Physicians , vol.110 , Issue.4 , pp. 321-332
    • Reed, J.A.1    Whitsett, J.A.2
  • 19
    • 0028824907 scopus 로고
    • Hematopoietic and lung abnormalities in mice with a null mutation of the common beta subunit of the receptors for granulocyte-macrophage colony-stimulating factor and interleukins 3 and 5
    • Robb L., Drinkwater C.C., Metcalf D., Li R., Kontgen F., Nicola N.A., Begley C.G. Hematopoietic and lung abnormalities in mice with a null mutation of the common beta subunit of the receptors for granulocyte-macrophage colony-stimulating factor and interleukins 3 and 5. Proc. Natl. Acad. Sci. U. S. A. 1995, 92:9565-9569.
    • (1995) Proc. Natl. Acad. Sci. U. S. A. , vol.92 , pp. 9565-9569
    • Robb, L.1    Drinkwater, C.C.2    Metcalf, D.3    Li, R.4    Kontgen, F.5    Nicola, N.A.6    Begley, C.G.7
  • 20
    • 77955546518 scopus 로고    scopus 로고
    • Patient-derived granulocyte/macrophage colony-stimulating factor autoantibodies reproduce pulmonary alveolar proteinosis in nonhuman primates
    • Sakagami T., Beck D., Uchida K., Suzuki T., Carey B.C., Nakata K., et al. Patient-derived granulocyte/macrophage colony-stimulating factor autoantibodies reproduce pulmonary alveolar proteinosis in nonhuman primates. Am. J. Respir. Crit. Care Med. 2010, 182(1):49-61.
    • (2010) Am. J. Respir. Crit. Care Med. , vol.182 , Issue.1 , pp. 49-61
    • Sakagami, T.1    Beck, D.2    Uchida, K.3    Suzuki, T.4    Carey, B.C.5    Nakata, K.6
  • 21
    • 0028236526 scopus 로고
    • Granulocyte/macrophage colony-stimulating factor deficient mice show no major perturbation of hematopoiesis but develop a characteristic pulmonary pathology
    • Stanley E., Lieschke G.J., Grail D., et al. Granulocyte/macrophage colony-stimulating factor deficient mice show no major perturbation of hematopoiesis but develop a characteristic pulmonary pathology. Proc. Natl. Acad. Sci. U. S. A. 1994, 91:5592-5596.
    • (1994) Proc. Natl. Acad. Sci. U. S. A. , vol.91 , pp. 5592-5596
    • Stanley, E.1    Lieschke, G.J.2    Grail, D.3
  • 22
    • 0036201268 scopus 로고    scopus 로고
    • GM-CSF regulates pulmonary surfactant homeostasis and alveolar macrophage-mediated innate host defense
    • Trapnell B.C., Whitsett J.A. GM-CSF regulates pulmonary surfactant homeostasis and alveolar macrophage-mediated innate host defense. Annu. Rev. Physiol. 2002, 64:775-802.
    • (2002) Annu. Rev. Physiol. , vol.64 , pp. 775-802
    • Trapnell, B.C.1    Whitsett, J.A.2
  • 23
    • 63849328934 scopus 로고    scopus 로고
    • Granulocyte/macrophage-colony-stimulating factor autoantibodies and myeloid cell immune functions in healthy subjects
    • Uchida K., Nakata K., Suzuki T., et al. Granulocyte/macrophage-colony-stimulating factor autoantibodies and myeloid cell immune functions in healthy subjects. Blood 2009, 113(11):2547-2556.
    • (2009) Blood , vol.113 , Issue.11 , pp. 2547-2556
    • Uchida, K.1    Nakata, K.2    Suzuki, T.3
  • 24
    • 69549118367 scopus 로고    scopus 로고
    • Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials
    • Wang D., Zhang S., Zhao H., Men A.Y., Parivar K. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J. Clin. Pharm. 2009, 49:1012-1024.
    • (2009) J. Clin. Pharm. , vol.49 , pp. 1012-1024
    • Wang, D.1    Zhang, S.2    Zhao, H.3    Men, A.Y.4    Parivar, K.5
  • 25
    • 84861861223 scopus 로고    scopus 로고
    • Mechanistic modeling of antigen sink effect for mavrilimumab following intravenous administration in patients with rheumatoid arthritis
    • Wang B., Lau Y.Y., Liang M., Vainshtein I., Zusmanovich M., Lu H., Magrini F., Sleeman M., Roskos L. Mechanistic modeling of antigen sink effect for mavrilimumab following intravenous administration in patients with rheumatoid arthritis. J. Clin. Pharm. 2012, 52(8):1150-1161.
    • (2012) J. Clin. Pharm. , vol.52 , Issue.8 , pp. 1150-1161
    • Wang, B.1    Lau, Y.Y.2    Liang, M.3    Vainshtein, I.4    Zusmanovich, M.5    Lu, H.6    Magrini, F.7    Sleeman, M.8    Roskos, L.9
  • 26
    • 76749100153 scopus 로고    scopus 로고
    • Prognostic and pathogenetic value of combining clinical and biochemical indices in patients with acute lung injury
    • Ware L.B., Koyama T., Billheimer D.D., Wu W., Bernard G.R., Thompson B.T., et al. Prognostic and pathogenetic value of combining clinical and biochemical indices in patients with acute lung injury. Chest 2010, 137(2):288-296.
    • (2010) Chest , vol.137 , Issue.2 , pp. 288-296
    • Ware, L.B.1    Koyama, T.2    Billheimer, D.D.3    Wu, W.4    Bernard, G.R.5    Thompson, B.T.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.